Guillaume Pfefer, Senda Biosciences CEO

Two years post-merg­er, Flag­ship’s Sen­da re­fines pipeline and re­plen­ish­es the bank 

Sen­da Bio­sciences will look a lit­tle dif­fer­ent than it did two years ago when Flag­ship Pi­o­neer­ing un­wrapped the bow on the ven­ture, a merg­er of Sen­da and Kin­tai Ther­a­peu­tics.

Orig­i­nal­ly home to six pre­clin­i­cal pro­grams with am­bi­tions for treat­ing mul­ti­ple scle­ro­sis, Parkin­son’s, col­orec­tal can­cer, chron­ic kid­ney dis­ease, obe­si­ty and oth­er dis­eases, the start­up is fine-tun­ing its path and will soon present a clear­er scope of its fu­ture.

For now, en route to its clin­i­cal en­try — a mile­stone that had been an­tic­i­pat­ed for this year, as of last June’s Se­ries B — the fledg­ling biotech is pick­ing up an­oth­er round of cap­i­tal, again from Flag­ship and a slate of new in­vestors.

With a $123 mil­lion Se­ries C, the Cam­bridge, MA, biotech hopes to have a re­fined vi­sion in the com­ing months as it turns off the lights on some of those pro­grams out of Kin­tai and its orig­i­nal blue­print.

“The next cou­ple of months, we’re go­ing to be start­ing to look at turn­ing the fo­cus of the com­pa­ny to­ward strat­e­gy goal area and spe­cif­ic pro­grams for IND de­c­la­ra­tion and first-in-hu­man,” CEO Guil­laume Pfe­fer told End­points News.

The biotech has been “de­pri­or­i­tiz­ing” mul­ti­ple pro­grams, in­clud­ing CKD, as it’s got­ten deep­er in­to mR­NA and ramped up ef­forts in im­muno-on­col­o­gy, in­fec­tious dis­ease and meta­bol­ic dis­ease, Pfe­fer said.

The com­pa­ny’s vi­sion is based on “in­ter­cel­lu­lar com­mu­ni­ca­tion across species,” as Sen­da has worked to glean in­sights from bac­te­ria, fun­gi, plants and oth­er sources to see how non-hu­man species have co-evolved with hu­mans — in­clud­ing the bac­te­ria with­in us. That in­volves look­ing at how they’ve evolved to com­mu­ni­cate with hu­man cells.

“We are look­ing at cell and gene ther­a­py and broad­ly speak­ing, com­pre­hen­sive pro­gram­ming of med­i­cine,” Pfe­fer said.

In its fund­ing an­nounce­ment, Sen­da said its plat­form can al­so “cre­ate new fron­tiers for ther­a­peu­tics and vac­cines” and maybe gene-edit­ing and pro­tein-based ther­a­pies down the road. Pri­or to join­ing the Flag­ship boat, Pfe­fer was a 25-year GSK vet­er­an who led shin­gles vac­cine de­vel­op­ment.

The goal is to reach cells, tis­sues and or­gans that pre­vi­ous med­i­cines have failed to reach. Sen­da wants its nanopar­ti­cles to tar­get spe­cif­ic cells and tis­sues in a “safe, re­peat­able way,” the CEO said. Pfe­fer is al­so a Flag­ship part­ner.

Af­ter tap­ping in­vestors, Sen­da is now pre­pared to move to­ward the clin­ic, and will look at hir­ing a chief med­ical of­fi­cer, Pfe­fer said. The biotech cur­rent­ly em­ploys about 75 peo­ple, he said.

The “in­ter­sys­tems bi­ol­o­gy” that serves as the foun­da­tion of Sen­da is the re­sult of a decade of re­search out of Flag­ship, which in­clud­ed tap­ping in­to the mi­cro­bio­me ex­per­tise and com­pu­ta­tion­al bi­ol­o­gy at the in­cu­ba­tor. On the mi­cro­bio­me side, Flag­ship has run in­to vary­ing hur­dles, in­clud­ing shut­ter­ing Kalei­do Bio­sciences ear­li­er this year, but bar­rel­ing ahead with Seres Ther­a­peu­tics, which is head­ed to the FDA with its C. dif­fi­cile drug.

Flag­ship, the biotech-cre­at­ing be­he­moth that has launched more than 80 star­tups in its 22-year his­to­ry, al­so re­cent­ly con­tributed to an­oth­er round of fi­nanc­ing for its spin­out Evelo, and has added a se­ries of new CEO-part­ners, in­clud­ing for­mer Ab­b­Vie leader Mike Sev­eri­no.

“In this mar­ket, it is a lit­tle bit tight, but in my ex­pe­ri­ence, great sci­ence and great da­ta at­tract great in­vestors and that re­mained true cer­tain­ly for us,” Pfe­fer said.

The Se­ries C in­clud­ed Flag­ship and new Sen­da back­ers Sam­sung Life Sci­ence Fund, Qatar In­vest­ment Au­thor­i­ty (QIA), Bluwave Cap­i­tal and Stage 1 Ven­tures. Ex­ist­ing in­vestors al­so joined, in­clud­ing Alexan­dria Ven­ture In­vest­ments, Longevi­ty Vi­sion Fund, Mayo Clin­ic, Part­ners In­vest­ment and State of Michi­gan Re­tire­ment Sys­tem.

Pi­o­neer­ing Click Chem­istry in Hu­mans

Reimagining cancer treatments

Cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, which is nearly one in six deaths. Recently, we have seen incredible advances in novel cancer therapies such as immune checkpoint inhibitors, cell therapies, and antibody-drug conjugates that have revamped cancer care and improved survival rates for patients.

Despite this significant progress in therapeutic targeting, why are we still seeing such a high mortality rate? The reason is that promising therapies are often limited by their therapeutic index, which is a measure of the effective dose of a drug, relative to its safety. If we could broaden the therapeutic indices of currently available medicines, it would revolutionize cancer treatments. We are still on the quest to find the ultimate cancer medicine – highly effective in several cancer types, safe, and precisely targeted to the tumor site.

Justin Klee (L) and Joshua Cohen, Amylyx co-CEOs (Cody O'Loughlin/The New York Times; courtesy Amylyx)

Ad­vo­cates, ex­perts cry foul over Amy­lyx's new ALS drug, cit­ing is­sues with price, PhI­II com­mit­ment

Not 24 hours after earning the first ALS drug approval in five years, Amylyx Pharmaceuticals’ Relyvrio is already drawing scrutiny. And it’s coming from multiple fronts.

In an investor call Friday morning, Amylyx revealed that it would charge about $158,000 per year, a price point that immediately drew backlash from ALS advocates and some outside observers. The cost reveal had been highly anticipated in the immediate hours after Thursday evening’s approval, though Amylyx only teased Relyvrio would cost less than previously approved drugs.

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Land­mark Amy­lyx OK spurs de­bate; Some... pos­i­tive? Alzheimer's da­ta; Can­cer tri­al bot­tle­neck; Sanofi's CRISPR bet; and more

Welcome back to Endpoints Weekly, your review of the week’s top biopharma headlines. Want this in your inbox every Saturday morning? Current Endpoints readers can visit their reader profile to add Endpoints Weekly. New to Endpoints? Sign up here.

After brief stops in Paris and Boston, John Carroll and the Endpoints crew are staying on the road in October with their return for a live/streaming EUBIO22 in London. The hybrid event fireside chats and panels on mRNA, oncology and the crazy public market. We hope you can join him there.

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Joshua Cohen (L) and Justin Klee, Amylyx co-CEOs

Up­dat­ed: Af­ter long and wind­ing road, FDA ap­proves Amy­lyx's ALS drug in vic­to­ry for pa­tients and ad­vo­ca­cy groups

For just the third time in its 116-year history, the FDA has approved a new treatment for Lou Gehrig’s disease, or ALS.

US regulators gave the thumbs-up to the drug, known as Relyvrio, in a massive win for patients and their families. The approval, given to Boston-area biotech Amylyx Pharmaceuticals, comes after two years of long and contentious debates over the drug’s effectiveness between advocacy groups and FDA scientists, following the readout of a mid-stage clinical trial in September 2020.

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George Church (courtesy EnPlusOne BioSciences)

George Church, Wyss sci­en­tists and North­pond chal­lenge con­ven­tion­al RNA man­u­fac­tur­ing with new biotech

RNA medicine has been at the forefront for the past few years, with the first RNA silencing therapy approved in 2018, and mRNA Covid vaccines following after. But flying under the radar has been the process of actually making RNA for these treatments.

That’s what Daniel Wiegand and Jonathan Rittichier have been working on in George Church’s lab for the past six years.

Friday morning, they unveiled EnPlusOne Biosciences, a biotech built on their RNA synthesis platform. Wiegand will serve as the Watertown, MA-based biotech’s CEO, and Rittichier will be CSO. And no different from his other startups, Church will be acting as scientific advisor. Its fourth co-founder, Dan Ahlstedt, joined through a Harvard Business School program, and will be COO.

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Up­dat­ed: Al­ny­lam re­in­forces APOL­LO-B patisir­an da­ta be­fore head­ing to the FDA

Weeks after uncorking some mostly positive data for patisiran in transthyretin-mediated (ATTR) amyloidosis with cardiomyopathy, Alnylam is bolstering its package with new exploratory and subgroup data before shipping it off to regulators.

The RNAi drug maintained “generally consistent” benefits in efficacy and quality of life across several prespecified subgroups at month 12, Alnylam announced on Friday afternoon, including age, baseline tafamidis use, ATTR amyloidosis type, baseline six-minute walk test score and others.

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Nooman Haque, head of life sciences and healthcare at Silicon Valley Bank, and John Carroll

I’m head­ed to Lon­don soon for #EU­BIO22. Care to join me?

It was great getting back to a live ESMO conference/webinar in Paris followed by a live pop-up event for the Endpoints 11 in Boston. We’re staying on the road in October with our return for a live/streaming EUBIO22 in London.

Silicon Valley Bank’s Nooman Haque and I are once again jumping back into the thick of it with a slate of virtual and live events on October 12. I’ll get the ball rolling with a virtual fireside chat with Novo Nordisk R&D chief Marcus Schindler, covering their pipeline plans and BD work.

#AAO22: J&J’s first look at com­mon eye dis­ease port­fo­lio pads the case for PhII of gene ther­a­py

CHICAGO — While the later-stage drug developers in the geographic atrophy field are near the finish line, Johnson & Johnson’s Janssen is taking a more deliberate route, with a treatment that it hopes to be a one-time fix.

The Big Pharma will take its Hemera Biosciences-acquired gene therapy into a Phase II study later this year in patients with GA, a common form of age-related macular degeneration that impacts about five million people worldwide. To get there, Janssen touted early-stage safety data at the American Academy of Ophthalmology annual conference Saturday morning, half a day after competitors Apellis and Iveric Bio revealed their own more-detailed Phase III analyses.

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Jerome Durso, Intercept Pharmaceuticals CEO

In­ter­cep­t's OCA fails a PhI­II NASH tri­al, rais­ing fresh doubts about its years­long quest for an OK

Intercept Pharmaceuticals has run into another big setback in its yearslong quest to win an approval for OCA in NASH. The biotech put out word Friday morning that its Phase III REVERSE study failed the primary endpoint for the liver disease, sending its share price into a tailspin.

There was no significant improvement in fibrosis among the patients suffering from cirrhosis who were treated with obeticholic acid, with investigators hunting for a minimum 1-stage histological improvement in the disease after 18 months of therapy.

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